Director, Oncology Early-Stage Clinical Scientist

Role Summary

Director, Oncology Early-Stage Clinical Scientist. Lead and coordinate the development of multiple studies of novel biological and small molecules for first in human (FIH), proof of mechanism (POM), early signs of efficacy (ESOE) and proof of concept (POC) studies in Oncology. Collaborate with the Global Development Lead and development team to establish and execute the early oncology clinical development plans. Develop clinical protocols and contribute as an individual contributor on clinical teams to meet enrollment and study delivery timelines.

Responsibilities

• Partner closely with the Global Development Lead (GDL) in the execution of the clinical development strategy and plan for the assigned molecule(s)/indication(s)
• Provide scientific leadership and execution of clinical studies, delivering innovative trial designs, high-quality trial execution, safety assessment, and interpretation of results
• Support execution for all FIH programs through proof-of-concept
• Set the clinical data review strategy, ensure quality data, review emerging data and trends, and present data to teams and governance bodies
• Conduct data review, analysis, and interpretation of trial data with GDL, Clinical Safety, and Biostatistics
• Serve as a technical resource for clinical issues raised by internal and external collaborators
• Support development of publications, abstracts, and presentations
• May sit on project teams to support clinical development implementation and contribute to milestones (start-up and delivery of ESOE and PoC trials)
• Lead preparation of clinical protocols and related documents (clinical development plans, INDs, CSRs, IBs, SAPs, regulatory documents)
• Foster transparent environments and build partnerships across therapeutic areas
• Coordinate with ORD and WRD; develop collaborations with internal and external partners
• Partner with Translational Oncology and Biomarker teams to integrate biomarker plans for early efficacy signs and patient stratification
• Establish relationships with external experts, regulators, and investigators to inform development plans and study designs
• Maintain up-to-date knowledge of literature and clinical development issues
• Perform other duties related to clinical programs and support departmental initiatives as requested

Qualifications

• Relevant PhD or PharmD with minimum 5 years of experience in a similar role in industry/CRO, OR
• MS with minimum 7 years of experience in a similar role in industry/CRO, OR
• BA/BS with minimum 10 years of experience in a similar role in industry/CRO
• Clinical Research experience in Phase 1 in Oncology, sponsor-led
• Experience or strong understanding of Oncology Drug Development, especially Early Development
• Strong knowledge of clinical procedures, ICH guidelines, GCP; familiarity with FDA, EMA, and global regulations
• Strong scientific writing and communication skills; experience writing protocols, ICDs, IBs, INDs; ability to interpret complex data
• Track record of scientific productivity (publications, posters, abstracts, presentations)
• Experience with Clinical Operations, Data Management, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, QA
• Ability to build consensus and drive change across all levels, including senior management
• Data listing review experience
• Critical thinker; able to work in fast-paced team-based matrix and independently
• Experience performing complex data analyses using JReview, SpotFire, SOCs-PRO or similar platforms

Skills

• Clinical development strategy and plan execution
• Study design and data interpretation
• Cross-functional collaboration and leadership
• Scientific writing and regulatory documentation
• Biomarker integration and patient stratification
• Data analysis using specialized tools

Education

• PhD or PharmD, or MS/BA with substantial industry/CRO experience as described

Additional Requirements

• 5-10% Travel
• Hybrid work location